VDRIVE W/V-SONO

K122659 · Stereotaxis, Inc. · DQX · Jul 26, 2013 · Cardiovascular

Device Facts

• Record ID: K122659
• Device Name: VDRIVE W/V-SONO
• Applicant: Stereotaxis, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Vdrive™ System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system. Compatible catheters at this time include Biosense Webster, Inc. Soundstart™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system. Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.

Device Story

Vdrive™ with V-Sono™ is a robotic system for remote manipulation of intracardiac echocardiography (ICE) catheters. System components include hardware (control box, adjustable arm, drive unit), software-driven user interfaces (tableside and dedicated controllers), and sterile, single-use V-Sono™ disposable kits (handle clamps, catheter support, drape). The physician operates the system from a control room to remotely control catheter advancement, retraction, rotation, and anterior-posterior deflection. Mechanical drive units translate user inputs into catheter movement. The system provides 3 axes of movement and variable speed control. It includes manual override and emergency stop capabilities. By stabilizing and navigating ICE catheters, the device facilitates visualization of cardiac structures during cardiac procedures. It is intended for use in the right atrium.

Clinical Evidence

No human clinical data provided. Evidence includes a comparative preclinical animal study evaluating manual versus Vdrive™ manipulation of ICE catheters using the V-Sono™ disposable. Bench testing included electrical safety, EMC compatibility, sterility, packaging, and verification/validation testing.

Technological Characteristics

System comprises electromechanical hardware, software-driven controllers, and sterile single-use disposable kits. Movement is mechanical across 3 axes. Sterilization of disposables via EtO. Connectivity includes tableside and remote control room interfaces. Software-driven control of catheter advancement, retraction, rotation, and deflection.

Indications for Use

Indicated for remote control of advancement, retraction, rotation, and anterior-posterior deflection of compatible ICE catheters (Biosense Webster Soundstar 3D, Acuson AcuNav) inserted into the right atrium for cardiac visualization during procedures.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Cardiodrive™ Advancement System (K071029)

Submission Summary (Full Text)

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## 510(k) Summary per 21CFR §807.92

... '

| Submitter's<br>information | Stereotaxis, Inc.<br>4320 Forest Park Ave, Suite 100<br>St. Louis, MO 63108<br>Contact: John Nadelin, VP Regulatory Affairs & Quality Systems<br>Phone: [phone] | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--|
| Device/<br>classification<br>name | Device Name: | Vdrive™ with V-Sono™ | |
| | Classification/Common name: | Wire, Guide, Catheter | |
| | Classification Number: | 870.1330 | |
| | Product Code: | DQX | |
| | Classification Panel: | Cardiovascular | |
| | Currently Marketed Substantially<br>Equivalent Device: | Cardiodrive™ Advancement System<br>(K071029) | |
| Device<br>description | The Vdrive™ with V-Sono™ is comprised of three major components, | | |
| | 1. Vdrive™ Hardware - control box, adjustable arm, drive unit and support<br>structure | | |
| | 2. Vdrive™ User Interface - combination of software driven 1) Tableside<br>Controller and 2) dedicated Vdrive™ Controller | | |
| | 3. V-Sono™ Disposable Kit - Handle Clamps (w/catheter inserts),<br>Telescoping Catheter Support and Drape. These components are<br>disposable, sterile, single use devices. | | |
| Intended use | The Vdrive™ System is intended to stabilize, navigate and control compatible<br>intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac<br>structures during the performance of cardiac procedures when used in conjunction<br>with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system.<br>Compatible catheters at this time include Biosense Webster, Inc. Soundstart™ 3D<br>Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of<br>ICE catheters have not been tested with the Vdrive™ system. | | |
| | Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement,<br>retraction, rotation and anterior-posterior deflection of compatible ultrasound<br>catheters inserted into the right atrium. | | |

Continued on next page

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## Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

| Device<br>Characteristic | Proposed Vdrive™ with V-<br>Sono™ | Currently Marketed<br>Cardiodrive® CAS |
|-------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------|
| Location of<br>Catheter tip | Right side of heart | Right or left side of heart |
| Placement of<br>catheter | Manual placement by<br>surgeon | Manual placement by<br>surgeon |
| Catheter Retraction/<br>Advancement | Mechanical | Mechanical |
| Variable Speed | Yes | Yes |
| Catheter Movement | Continuous | Stepped or Continuous |
| Emergency Stop<br>Option | Manual | Manual |
| Manual Override | Yes | Yes |
| Single Use | Yes | Yes |
| Sterilization<br>Method | EtO | EtO |
| Control of catheter<br>movement | Mechanical | Mechanical (advance &<br>retract) and Magnetic (steer) |
| Compatible<br>Catheters | BWI Soundstar 3D<br>Ultrasound Catheters and<br>Acuson AcuNav Ultrasound<br>Catheters | BWI Magnetic EP Catheters |
| No: axes of<br>movement | 3 | 1 |
| Control Room User<br>Interface | Yes | Yes |
| SW driven | Yes | Yes |

Performance Clinical performance data from a related Vdrive™ system was submitted in support data of this application. A comparative preclinical study has been conducted in animals with manual versus Vdriv™e manipulation of an Intracardiac Echocardiography (ICE) catheter using the V-Sono™ disposable.

> Performance testing for electrical safety, EMC compatibility, sterility, packaging, and verification and validation testing were presented.

Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive™ with V-Sono™ device is safe and effective for its intended use.

Date summary prepared: July 25, 2013

Technological characteristics

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 26, 2013

Stereotaxis, Inc. c/o Diane Horwitz, Ph.D., RAC Regulatory Affairs Stereotaxis 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108

Re: K122659

> Trade/Device Names: Vdrive with V-sono Regulatory Number: 21 CFR 870.1330 Regulation Name: Wires. Guide, Catheter Regulatory Class: Class II (Two) Product Code: DQX, DXX Dated: July 22, 2013 Received: July 22, 2013

Dear Dr. Horwitz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Diane Horwitz, Ph.D., RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M. A. Zillmann

for Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number: K122659

Device Name: Vdrive™ with V-SonoTM

The Vdrive™ System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system.

Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement, retraction. rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Z. Hillerman